{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63141",
      "recalling_firm": "Greatbatch Medical",
      "address_1": "2300 Berkshire Ln N",
      "address_2": "N/A",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in MA.",
      "recall_number": "Z-2459-2012",
      "product_description": "Boston Scientific, Z Flex 270,  Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441.     To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.",
      "product_quantity": "787",
      "reason_for_recall": "During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.",
      "recall_initiation_date": "20120906",
      "center_classification_date": "20120926",
      "termination_date": "20150122",
      "report_date": "20121003",
      "code_info": "Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843",
      "more_code_info": ""
    }
  ]
}